Global Product Quality Strategy Director

GlaxoSmithKline; Zebulon (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

GlaxoSmithKline seeks a Product Quality Strategy Director to lead end-to-end quality strategy for critical assets from pivotal readiness through lifecycle management. You will serve as the One Quality Voice across CMC, QMS, R&D, and manufacturing, guiding decisions with risk-based recommendations.

As a senior leader, you will drive governance, regulatory submissions readiness, and lifecycle changes, coordinating cross-functional teams to ensure patient safety, supply continuity, and

Qualifications

• Bachelor's degree in a science or related field.
• Minimum 10 years of pharmaceutical-industry experience across Quality and/or Technical functions.
• Experience in GMP.
• Experience with product lifecycle management.
• Experience with product quality risk management and new product introduction.
• Experience with regulatory submissions and inspection readiness.
• Matrix leadership experience.
• Governance participation experience.

Responsibilities

• Develop, maintain, and integrate end-to-end Product Quality Strategy for assigned assets from pivotal readiness through launch and lifecycle management.
• Lead the Product Quality Team and influence cross-functional partners to align priorities and readiness plans.
• Represent Quality as the One Quality Voice at governance forums and escalate issues through proper routes.
• Provide Quality leadership for pivotal activities including regulatory submissions and post-approval readiness.
• Drive proactive product quality risk detection, governance, mitigation, and senior governance visibility.
• Coordinate matrix oversight of QMS and lifecycle processes for changes, CAPAs, and regulatory submissions.
• Drive end-to-end Product Quality for vaccines or medicines to strengthen patient outcomes and supply continuity.
• Serve as global SME for new product introduction and lifecycle change management.

Skills

GMP

Lifecycle Management

Matrix Leadership

Risk Management

Quality Strategy

Data Integrity

Education

Bachelor's degree

Master's degree

Tools

GxP Regulations

Regulatory Submissions

Quality Systems

Job description

GlaxoSmithKline seeks a Product Quality Strategy Director to lead end-to-end quality strategy for critical assets from pivotal readiness through lifecycle management. You will serve as the One Quality Voice across CMC, QMS, R&D, and manufacturing, guiding decisions with risk-based recommendations.

As a senior leader, you will drive governance, regulatory submissions readiness, and lifecycle changes, coordinating cross-functional teams to ensure patient safety, supply continuity, and